Study in Nature Medicine Shows Superior Outcomes for Patients in The Leukemia & Lymphoma Society’s Paradigm-Shifting Beat AML Clinical Trial

RYE BROOK, N.Y., Oct. 26, 2020 /PRNewswire/ — Patients participating in The Leukemia & Lymphoma Society’s (LLS) groundbreaking precision medicine Beat AML Master Clinical Trial had superior outcomes compared to acute myeloid leukemia (AML) patients who opted for standard chemotherapy treatment, according to findings published today in the prestigious Nature Medicine journal.


Leukemia & Lymphoma Society logo (PRNewsfoto/The Leukemia & Lymphoma Society)

The Beat AML trial achieved its primary endpoint by showing genomic analysis of the leukemia cells to identify AML subtypes can be completed within an unprecedented seven days, giving patients, caregivers and their doctors ample time to make a more personalized treatment decision without risking the patient’s chance for survival.

In other key findings, the study demonstrated a paradigm shift in how patients diagnosed with AML should be treated, proving that using genetic information to match patients to targeted therapies leads to better survival rates than the traditional one-size-fits all treatment approach.

AML is an extremely fast-moving cancer of the marrow and blood, affecting 21,000 people in the U.S. a year, and killing 10,000. For decades patients have been given the same treatments almost immediately upon diagnosis because waiting allows the cancer cells to grow out of control. This standard of care involves either infusion of a combination of two chemotherapies, cytarabine and daunorubicin, or treatment with a so-called hypomethylating agent, a drug that unleashes signals allowing the cancer cells to die.

“The study shows that delaying treatment up to seven days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival compared to patients who opted for standard of care,” said John C. Byrd, MD, D. Warren Brown Chair of Leukemia Research of The Ohio State University, and one of the Beat AML leads and corresponding author of the study. “This patient-centric study shows that we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual case.”

Going on the Offensive Against AML

Recognizing the urgent need to do better for AML patients, LLS launched this clinical trial in fall 2016 to test multiple novel targeted therapies at major cancer centers across the U.S., in newly diagnosed AML patients aged 60 and older. In a historic first for cancer clinical trials, LLS is the first non-profit health organization to sponsor a trial and hold the IND (Investigational New Drug) application from the U.S. Food and Drug Administration. Beat AML partnered with Foundation Medicine Inc. to employ next generation genomic sequencing to rapidly analyze the patients’ cancer cells, and identify the patients’ AML subtype so they can be given a targeted therapy within a safe timeframe.

“The breadth of this collaboration, with every clinician, cancer center, pharmaceutical partner and all of the many operations and technical support companies, all unified in working toward the common goal of building a new model for tackling

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Jeff Bridges announces lymphoma diagnosis, says he’s ‘starting treatment’

Jeff Bridges announced Monday night that he had been diagnosed with lymphoma.

The actor, 70, shared the news in a series of tweets.

“As the Dude would say.. New S**T has come to light,” he wrote, referencing his iconic role in “The Big Lebowski.”

“I have been diagnosed with Lymphoma. Although it is a serious disease, I feel fortunate that I have a great team of doctors and the prognosis is good,” he said. “I’m starting treatment and will keep you posted on my recovery.”

He also shared the news on Facebook and Instagram.

Bridges did not share any details about his prognosis or what stage the illness was at. Lymphoma is a blood cancer that affects lymphocytes, a type of white blood cell that defends the body against bacteria and viruses. According to the Lymphoma Research Foundation, both non-cancerous and cancerous lymphocytes can travel and spread throughout the body.

There are multiple different types of lymphoma, including Hodgkin and Non-Hogdkin lymphoma. Bridges did not specify which he had been diagnosed with.

Related: From his Houston Texans teammates and National Football League opponents to family members and an 8-year-old superfan, David Quessenberry has countless allies in his fight against non-Hodgkin’s lymphoma.At Thursday morning’s practice in Houston, players and coaches sported “Texans for DQ” T-shirts for DQ Strong Day, the team’s tribute to the second-year offensive tackle in support of the

Fans and followers quickly filled the comments section of the post with well-wishes.

“Sending you and your family love and healing,” wrote actor Patricia Arquette.

“You’re a fighter,” added George Takei. “You can beat this.”

Many chimed in with “Big Lebowski”-themed messages.

“If anyone can abide this with grace, we know it’s you dude,” wrote one fan, along with a GIF from the famous 1998 movie.

“I’m sorry to hear this. I’m hoping for your full recovery, and know that ‘the Dude’ will abide,” wrote another Twitter user.

Users also added prayers for a speedy recovery and positive prognosis.

“Our thoughts go out to Jeff and his family during this challenging time and they have our love and support. We wish him a safe and full recovery,” FX, Touchstone Television, Hulu and FXP said in a statement to Variety; Bridges stars in the FX on Hulu series “The Old Man,” which was supposed to air in June before COVID-19 halted production. “And, as Jeff always says, ‘We are all in this together.’ Jeff, we are all in this together with you.”

In a second post, Bridges thanked family and friends for their “love and support.”

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EMA OKs First CAR T-Cell Therapy for Mantle Cell Lymphoma

The European Medicines Agency (EMA) today recommended granting conditional marketing authorization to brexucabtagene autoleucel (Tecartus), making it the first approved chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in the European Union.

Brexucabtagene autoleucel is the third CAR T-cell therapy to be recommended for approval in Europe, but the only one for this indication.

The agent was approved for the same use in the United States earlier this year and was described by one expert as representing a “new frontier” in the treatment of MCL.

The new agent addresses an unmet need in MCL for patients who relapse or progress despite available therapies.

The current standard of care for this cancer includes stem cell transplantation and various therapy regimens, including Bruton’s tyrosine kinase (BTK) inhibitors, all of which are often initially effective. However, patients commonly relapse or stop responding to treatment, according to the EMA.

“This opinion is an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma,” said Ken Takeshita, MD, global head of clinical development at Kite, the agent’s manufacturer, in a press statement.

It is based on safety and efficacy results from the multicenter, single-arm ZUMA-2 trial in 74 adult patients with refractory or relapsed MCL who had received at least two prior therapies.

During the study’s 12-month follow-up period, 84% of patients had a partial response and 59% had a complete response.

The most common side effects are cytokine release syndrome, infections, and encephalopathy. Monitoring and mitigation strategies for these side effects are described in the product information and the agent’s risk management plan.

Further efficacy and safety data are being collected as part of long-term follow-up from the pivotal study and an additional registry-based study.

Brexucabtagene autoleucel was supported through EMA’s Priority Medicines (PRIME) initiative, which provides early and enhanced scientific and regulatory support to medicines that have the potential to address unmet needs.

Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday, and had bylines in WashingtonPost.com, MSNBC, and Yahoo. Reach him by email and follow him on Twitter.

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